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This is an example for the required design parameter information in a PMTA submission for one type of tobacco product Electronic Nicotine Delivery Systems (ENDS). There are many more and various types of tobacco products, and their parameters can be found in the in the PMTA Final Rule. The applicant submitting for PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results for all these parameters.

Device Identifiers (DI) is a study reference dataset that provides a mechanism for uniquely identifying a device. The primary purpose of this dataset is to provide a list of the devices used in a study and to provide identifying information for each device, such as device type, manufacturer, model name, etc., as applicable. All identifying information is grouped by the Sponsor Device Identifier (SPDEVID), a consistent variable, that is available for use in other domains where data pertaining to the device may be found.

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Name	di

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The Device-In-Use (DU) domain represents properties of the device as used.

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Name	du

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The RELDEV dataset is used to record the relationships between the ENDS device and it's components.

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Name	reldev

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illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

Dataset wrap

Name	to

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOSCAT	TOVAL	TOVALU
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER	Cigarettes
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER	Filtered
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIER	Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Treetop Menthol King Size
5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR	HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	20	CIGARETTE
7	TOB07	TO	CIG01a	7	LENGTH	Length	NEW PRODUCT	PRODUCT DESCRIPTOR	86.0	mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	NEW PRODUCT	PRODUCT DESCRIPTOR	26.0	mm
9	TOB07	TO	CIG01a	9	VENTLTOT	Total Ventilation	NEW PRODUCT	PRODUCT DESCRIPTOR	10.0	%
10	TOB07	TO	CIG01a	10	CHARFLAV	Characterizing Flavor	NEW PRODUCT	PRODUCT DESCRIPTOR	MENTHOL

The manufacturing parameter specifications of the cigarette tobacco product as intended for use are represented in the PD domain The following example shows the target, minimum, and maximum values associated with each of 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.

Dataset wrap

Name	pd

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	IGDCMPID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU
1	TOB07	PD	CIG01a		1	LENGTH	Length	84	83.5	84.5	mm
2	TOB07	PD	CIG01a		2	CIRCUMF	Circumference	24.8	24.6	25	mm
3	TOB07	PD	CIG01a		3	TBFLMASS	Tobacco Filler Mass	783	753	814	mg
4	TOB07	PD	CIG01a		4	MOISTURE	Moisture	13	12	14	%
5	TOB07	PD	CIG01a	Burley tobacco	5	TOCUTSIZ	Tobacco Cut Size	22	20	24	cuts/in
6	TOB07	PD	CIG01a	Reconstituted tobacco	6	TOCUTSIZ	Tobacco Cut Size	27	25	29	mm
7	TOB07	PD	CIG01a		7	VENTLFLT	Filter Ventilation	30	23	37	%
8	TOB07	PD	CIG01a		8	TPNPLGTH	Tipping Paper Length	31	30	32	mm
9	TOB07	PD	CIG01a		9	CBPPOR	Cigarette Base Paper Porosity	50	45	55	Cu
10	TOB07	PD	CIG01a		10	CBPPERM	Cigarette Base Paper Permeability	50	45	55	Cu
11	TOB07	PD	CIG01a		11	CPBPOR	Cigarette Paper Band Porosity	10	0.2	13	Cu
12	TOB07	PD	CIG01a		12	CPBPERM	Cigarette Paper Band Permeability	10	0.2	13	Cu
13	TOB07	PD	CIG01a		13	CPBDIFF	Cigarette Paper Band Diffusivity	0.05	0.001	0.100	cm2/s
14	TOB07	PD	CIG01a		14	CPBWID	Cigarette Paper Band Width	7	6.7	7.3	mm
15	TOB07	PD	CIG01a		15	CPBSPC	Cigarette Paper Band Space	20	19.8	20.2	mm
16	TOB07	PD	CIG01a		16	FLTREFF	Filter Efficiency	30	25	35	%
17	TOB07	PD	CIG01a		17	DPF	Denier Per Filament	4	3.6	4.4
18	TOB07	PD	CIG01a		18	TDENIER	Total Denier	30000	29100	30900	g/9000m
19	TOB07	PD	CIG01a		19	FLTRDEN	Filter Density	0.1234	0.105	0.1419	g/cm3
20	TOB07	PD	CIG01a		20	FLTRLGTH	Filter Length	25	24.5	25.5	mm
21	TOB07	PD	CIG01a		21	FLTPRDRP	Filter Pressure Drop	60	51	69	mm H2O
22	TOB07	PD	CIG01a		22	TORODDEN	Tobacco Rod Density	0.2678	0.2437	0.2919	g/cm3
23	TOB07	PD	CIG01a		23	CIGPLGTH	Cigarette Paper Length	53	52	54	mm

Finally, the PT domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

Dataset wrap

Name	pt

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	IGDCMPID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM
1	TOB07	PT	CIG01a		1	LENGTH	Length	DESIGN PARAMETER TESTING	83.9	mm	83.9	83.9	mm	1
2	TOB07	PT	CIG01a		2	CIRCUMF	Circumference	DESIGN PARAMETER TESTING	24.9	mm	24.9	24.9	mm	1
3	TOB07	PT	CIG01a		3	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER TESTING	779	mg	779	779	mg	1
4	TOB07	PT	CIG01a		4	MOISTURE	Moisture	DESIGN PARAMETER TESTING	13.1	%	13.1	13.1	%	1
5	TOB07	PT	CIG01a	Burley tobacco	5	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	22	cuts/in	22	22	cuts/in	1
6	TOB07	PT	CIG01a	Reconstituted tobacco	6	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	27	mm	27	27	mm	1
7	TOB07	PT	CIG01a		7	VENTLFLT	Filter Ventilation	DESIGN PARAMETER TESTING	35	%	35	35	%	1
8	TOB07	PT	CIG01a		8	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER TESTING	30	mm	30	30	mm	1
9	TOB07	PT	CIG01a		9	CBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER TESTING	48	Cu	48	48	Cu	1
10	TOB07	PT	CIG01a		10	CBPPERM	Cigarette Base Paper Permeability	DESIGN PARAMETER TESTING	50	Cu	50	50	Cu	1
11	TOB07	PT	CIG01a		11	CPBPOR	Cigarette Paper Band Porosity	DESIGN PARAMETER TESTING	9.8	Cu	9.8	9.8	Cu	1
12	TOB07	PT	CIG01a		12	CPBPERM	Cigarette Paper Band Permeability	DESIGN PARAMETER TESTING	10	Cu	10	10	Cu	1
13	TOB07	PT	CIG01a		13	CPBDIFF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER TESTING	0.06	cm2/s	0.06	0.06	cm2/s	1
14	TOB07	PT	CIG01a		14	CPBWID	Cigarette Paper Band Width	DESIGN PARAMETER TESTING	7.1	mm	7.1	7.1	mm	1
15	TOB07	PT	CIG01a		15	CPBSPC	Cigarette Paper Band Space	DESIGN PARAMETER TESTING	19.9	mm	19.9	19.9	mm	1
16	TOB07	PT	CIG01a		16	FLTREFF	Filter Efficiency	DESIGN PARAMETER TESTING	28	%	28	28	%	1
17	TOB07	PT	CIG01a		17	DPF	Denier Per Filament	DESIGN PARAMETER TESTING	4.1		4.1	4.1		1
18	TOB07	PT	CIG01a		18	TDENIER	Total Denier	DESIGN PARAMETER TESTING	29900	g/9000m	29900	29900	g/9000m	1
19	TOB07	PT	CIG01a		19	FLTRDEN	Filter Density	DESIGN PARAMETER TESTING	0.1112	g/cm3	0.1112	0.1112	g/cm3	1
20	TOB07	PT	CIG01a		20	FLTRLGTH	Filter Length	DESIGN PARAMETER TESTING	25	mm	25	25	mm	1
21	TOB07	PT	CIG01a		21	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER TESTING	62	mm H2O	62	62	mm H2O	1
22	TOB07	PT	CIG01a		22	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER TESTING	0.2701	g/cm3	0.2701	0.2701	g/cm3	1
23	TOB07	PT	CIG01a		23	CIGPLGTH	Cigarette Paper Length	DESIGN PARAMETER TESTING	53	mm	53	53	mm	1

References:

International Organization for Standardization. ISO 9512:2019(en) - Cigarettes — Determination of ventilation — Definitions and measurement principles. ISO; June 2019. Accessed October 15, 2023. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
Song M-A, Benowitz NL, Berman M, et al. Cigarette filter ventilation and its relationship to increasing rates of lung adenocarcinoma. J Natl Cancer Inst. 2017;109(12):djx075. https://doi.org/10.1093/jnci/djx075

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